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Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan

Primary Purpose

Postoperative Supraventricular Tachyarrythmia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ONO-1101
Sponsored by
Ono Pharma USA Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Supraventricular Tachyarrythmia focused on measuring ONO-1101,Landiolol Hydrochloride, Postoperative, Supraventricular Tachyarrhythmia

Eligibility Criteria

21 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 20-80 years old Postoperative supraventricular tachyarrhythmias (sinus tachycardia, those with a heart rate of 120 beats/min or higher, and supraventricular arrhythmia, those with a heart rate of 100 beats/min or higher) Within 7 days postoperatively Other inclusion criteria as specified in the protocol Exclusion Criteria: Acute myocardial infarction (within 1 month after onset) Severe heart failure (New York Heart Association functional class III or higher) Atrioventricular block (grade II or higher),or sick sinus syndrome Other exclusion criteria as specified in the protocol

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Percentage of patients achieving 20% reduction in heart rate at each dose

    Secondary Outcome Measures

    Heart Rate, Blood pressure and 12-lead ECG

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    October 10, 2012
    Sponsor
    Ono Pharma USA Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00212680
    Brief Title
    Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan
    Official Title
    Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1996 (undefined)
    Primary Completion Date
    April 2006 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ono Pharma USA Inc

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the dose-dependent effects of ONO-1101 on efficacy and safety in patients with postoperative supraventricular tachyarrhythmias.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Supraventricular Tachyarrythmia
    Keywords
    ONO-1101,Landiolol Hydrochloride, Postoperative, Supraventricular Tachyarrhythmia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ONO-1101
    Primary Outcome Measure Information:
    Title
    Percentage of patients achieving 20% reduction in heart rate at each dose
    Secondary Outcome Measure Information:
    Title
    Heart Rate, Blood pressure and 12-lead ECG

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 20-80 years old Postoperative supraventricular tachyarrhythmias (sinus tachycardia, those with a heart rate of 120 beats/min or higher, and supraventricular arrhythmia, those with a heart rate of 100 beats/min or higher) Within 7 days postoperatively Other inclusion criteria as specified in the protocol Exclusion Criteria: Acute myocardial infarction (within 1 month after onset) Severe heart failure (New York Heart Association functional class III or higher) Atrioventricular block (grade II or higher),or sick sinus syndrome Other exclusion criteria as specified in the protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Project Leader, Development Planning
    Organizational Affiliation
    Ono Pharmaceutical Co. Ltd
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan

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